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U.K. Regulators Sour on Novartis Breast Cancer Drug Afinitor

NICE's draft guidance says the drug is not cost-effective.

The U.K.'s National Institute for Health and Clinical Excellence, or NICE, has decided not to recommend Novartis' (NYSE:NVS) Afinitor for treating advanced breast cancer in draft guidance it released yesterday.

NICE turned away the drug in the treatment of HER2 negative, hormone-receptor-positive forms of the cancer due to questions over its cost-effectiveness, a major hurdle for the U.K. as it deals with rising health care costs and tightening budgets.

The decision isn't set in stone, since it is draft guidance, but Novartis and cancer patient groups expressed disappointment at NICE's decision. This isn't the first time the U.K. agency has turned away a breast cancer treatment; NICE has also given the thumbs-down to therapies from big pharma rivals, such as Roche's Avastin.

NICE has yet to come up with final guidance on Afinitor, although the agency's Chief Executive, Sir Andrew Dillon, was quoted in NICE's statement as saying, "While the independent Appraisal Committee acknowledged that everolimus [Afinitor] may offer a step change in treatment by restoring sensitivity of the tumour to hormone therapy, the evidence highlighted uncertainty relating to how much the treatment extends overall survival. Using the most appropriate estimates, the committee concluded that everolimus is not a cost-effective treatment option for the NHS."

While the ruling could hurt Novartis' goals, Afinitor is still expected to hit blockbuster status, with one analyst last year projecting peak sales exceeding $2 billion by 2017.